Day TwoTuesday, 16 September 2025 - CT (Central Time)

• Evaluate the administration's approach to pharmaceutical imports, including tariff policies affecting products from China, India, and the EU, and their impact on cost structures and supply decisions
• Interpret "Made in America" requirements for Federal Supply Schedule (FSS) products and their implications for manufacturing, sourcing strategies, and government contracting
• Investigate the intersection of tariff policies with supply chain pressures, including shortage mitigation efforts, onshoring incentives, and manufacturing quality requirements
• Formulate effective approaches for navigating cross-border product movements, including customs classifications, country-of-origin determinations, and documentation requirements

Pharmaceutical manufacturers and third-parties (e.g., GoodRx) are increasingly adopting consumer-directed health care initiatives. These initiatives, which focus on giving patients enhanced choices and access to health care, may offer consumers “one stop” access to prescription drugs through cash-pay discount drug programs (that operate outside of insurance), telehealth prescribing, and/or online pharmacies. The market for these types of offerings is rapidly developing, presenting alternative channels to commercialize drugs, with a wide range of related legal considerations. This session will:

• Identify trends in consumer-directed health care initiatives, taking a detailed look at common structures
• Provide an overview of potential legal considerations and concerns
• Examine recent government scrutiny and enforcement actions
• Highlight key “watch outs” in implementing initiatives and options to mitigate risk

• Outline essential MFP requirements and implementation status, including practical approaches for meeting program guidelines and strategic considerations for compliance across different company sizes
• Navigate treasury operation changes from traditional 45-day cycles to daily payment requirements, establishing cross-system integration between government pricing platforms and financial systems
• Guide manufacturers through September deadline preparations, covering documentation requirements, operational readiness assessments, and compliance verification processes
• Develop robust data governance frameworks for maintaining historical pricing information required for Medicare negotiations, including strategies for source documentation preservation and audit preparation

• Understand the specific considerations for physician-administered drugs entering Medicare negotiation in Round 3, including ASP reporting requirements and distinct operational challenges
• Assess the potential marketplace impacts of MFP on Part B drug reimbursement, formulary positioning, and future investment decisions for injectable and infused therapies
• Explore strategies for communicating with providers and health systems about Part B drug pricing changes and their potential effects on acquisition costs and administration fees
• Examine policy considerations and potential regulatory changes that may affect Part B drug pricing and reimbursement as IRA implementation evolves

• Examine financial challenges and business decisions for products facing underwater pricing in Medicaid

• Explore portfolio management approaches and market repositioning strategies from established manufacturers

• Evaluate cross-functional frameworks for addressing negative margin products, including legal and market access considerations

• Develop actionable insights for mature brands in an increasingly complex rebate environment

• Navigate evolving state transparency requirements while effectively safeguarding sensitive pricing information through proven trade secret protection strategies
• Understand current enforcement priorities and respond strategically to state inquiries based on recent case studies from Oregon, New York, and Colorado
• Develop cross-functional protocols to streamline reporting processes while maintaining consistency across multiple state submissions
• Implement practical approaches to engage constructively with state regulators while advocating for reasonable interpretations of disclosure requirements

• Analyze early market signals regarding PBM and health plan treatment of MFP-negotiated products, including formulary positioning, prior authorization requirements, and utilization management strategies
• Develop commercial strategies that address the changing rebate dynamics for products subject to MFP, including approaches to maintaining competitive formulary positioning
• Understand the implications of IRA implementation on biosimilar and generic competition, including potential shifts in market entry timing and pricing strategies
• Explore the evolving landscape of patient affordability programs for products subject to MFP, including benefit design optimization and alternative access models